Personalized Multi-peptide Vaccination in Combination With the TLR1/2 Ligand XS15 in Cancer Patients

NCT05014607 | Unknown

• 1 other identifier: InHeVac01
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this project is to provide personalized multi-peptide vaccination in combination with the TLR1/2 ligand XS15 to individual patients with advanced solid and hematological malignancies without any approved treatment options.

Conditions

Cancer

Interventions

Personalized multi-peptide vaccine BIOLOGICAL

Peptide vaccine: Personalized multi-peptide vaccine cocktails consisting of 200-300µg each of 1-10 tumor-associated peptides selected individually based on the patient-individual HLA allotypes and HLA ligandome analysis of tumor cells Peptides are synthesized in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen and will be formulated at the GMP-Center of the University Hospital Tübingen. Peptides will be administered subcutaneously (s.c.) together with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant. Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned. Treatment schedule: Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned, depended on the induction of peptide-specific T-cell responses.

Also known as: Adjuvants XS15 and Montanide ISA 51 VG

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented diagnosis of advanced malignant disease
• Advanced malignant disease without any available standard of care treatment option
• Low tumor cell burden
• Live expectancy \> 6 month
• Ability to understand and voluntarily sign an informed consent form.
• Ability to adhere to the study visit schedule and other protocol requirements
• Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

You may not qualify if:

• Pregnant or lactating females.
• Treatment regimens inducing sever T cell deficiencies
• Treatment-related side effect \> CTC grade 2 (CTCAE V5.0
• Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to vaccination
• Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Related Links

• Department CCU Translational Immunology

MeSH Terms

Conditions

Neoplasms

Study Officials

• Helmut R Salih, MD

  CCU Translational Immunology, University Hospital Tübingen, Germany

  STUDY CHAIR

Central Study Contacts

Juliane S Walz, MD

CONTACT

07071/2968746; kketi@med.uni-tuebingen.de

Helmut R Salih, MD

CONTACT

07071/2968746; kketi@med.uni-tuebingen.de

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 20, 2021
• Last Updated: May 9, 2024

Record last verified: 2024-05